Boston Scientific Corporation Recalls EMBLEM S | 合法醫療器材資訊網

2021年2月19日—EMBLEMS-ICDisanimplantabledefibrillator.Insomedevices,moisturemaygetinsideandkeepthedevicefromshockingthehearttofix ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) Lots: See below Model: S-ICD A209 and MRI S-ICD A219 Distribution Dates: June 1, 2015 – September 30, 2019 Devices Recalled in the U.S.: 2825 Date Initiated by Firm: December 2, 2020 Device Use

The EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) is part of the Boston Scientific S-ICD System. The Boston Scientific S-ICD is an implantable cardioverter defibrillator[1] that is intended to provide electrical shock to stop dangerously fast heart rhythms and pacing for a short time after shocks if needed. These cardiac d...

EMBLEM MRI S | 合法醫療器材資訊網

The EMBLEM MRI S-ICD is the only subcutaneous implantable defibrillator that provides protection from both sudden cardiac death and the risks and ... Read More

EMBLEM™ MRI S | 合法醫療器材資訊網

The EMBLEM MRI Subcutaneous Defibrillator (S-ICD) System is an established, first-choice therapy that provides protection for patients at risk for sudden ... Read More

EMBLEM MRI S | 合法醫療器材資訊網

The EMBLEM MRI S-ICD is the second device in the EMBLEM S-ICD family and builds on previous enhancements in size, longevity and remote patient management. Read More

EMBLEM™ S-ICD, EMBLEM™ MRI S | 合法醫療器材資訊網

Record 10 - 20 — The device accepts one EMBLEM S-ICD subcutaneous electrode with an SQ-1 S-ICD connector1. The device is also compatible with the Cameron Health ... Read More

EMBLEM MRI S | 合法醫療器材資訊網

Subcutaneous Implantable Defibrillator. System Specifications. The EMBLEM MRI S-ICD is the second device in the EMBLEM S-ICD family and builds on previous ... Read More

EMBLEM™ MRI S-ICD System | 合法醫療器材資訊網

The EMBLEM MRI S-ICD has been built upon the excellent clinical performance of the world's first subcutaneous ICD; providing protection for patients at risk ... Read More

ImageReady™ MR | 合法醫療器材資訊網

MRI Compatibility. The EMBLEM™ MRI and EMBLEM™ S-ICDs are FDA-approved for use with any S-ICD electrode as an ImageReady MR-Conditional System. Read More

Boston Scientific Corporation Recalls EMBLEM S | 合法醫療器材資訊網

2021年2月19日 — EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix ... Read More

相關資訊整理

Boston Scientific Corporation Recalls EMBLEM S | 合法醫療器材資訊網

EMBLEM MRI S | 合法醫療器材資訊網

EMBLEM™ MRI S | 合法醫療器材資訊網

EMBLEM MRI S | 合法醫療器材資訊網

EMBLEM™ S-ICD, EMBLEM™ MRI S | 合法醫療器材資訊網

EMBLEM MRI S | 合法醫療器材資訊網

EMBLEM™ MRI S-ICD System | 合法醫療器材資訊網

ImageReady™ MR | 合法醫療器材資訊網

Boston Scientific Corporation Recalls EMBLEM S | 合法醫療器材資訊網

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